Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine
The aim of this study is to develop an orally disintegrating film (ODF) containing a microparticulate measles vaccine formulation for buccal delivery. The measles vaccine microparticles were made with biocompatible and biodegradable bovine serum albumin (BSA) and processed by spray drying. These vac...
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| Veröffentlicht in: | AAPS PharmSciTech 2017-02, Vol.18 (2), p.283-292 |
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| creator | Gala, Rikhav P. Popescu, Carmen Knipp, Gregory T. McCain, Robyn R. Ubale, Ruhi V. Addo, Richard Bhowmik, Tuhin Kulczar, Christopher D. D’Souza, Martin J. |
| description | The aim of this study is to develop an orally disintegrating film (ODF) containing a microparticulate measles vaccine formulation for buccal delivery. The measles vaccine microparticles were made with biocompatible and biodegradable bovine serum albumin (BSA) and processed by spray drying. These vaccine microparticles were incorporated in the ODF, consisting of Lycoat RS720®, Neosorb P60W® and Tween 80. The yield of the microparticles was approximately 85–95%,
w
/
w
. The mean size of the vaccine microparticles was 3.65 ± 1.89 μm and had a slightly negative surface charge of 32.65 ± 2.4 mV. The vaccine particles were nontoxic to normal cells at high concentrations (500 μg/2.5 × 10
5
cells) of vaccine particles. There was a significant induction of innate immune response by vaccine microparticles which was observed
in vitro
when compared to blank microparticles (
P
|
| doi_str_mv | 10.1208/s12249-016-0566-3 |
| format | Article |
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w
/
w
. The mean size of the vaccine microparticles was 3.65 ± 1.89 μm and had a slightly negative surface charge of 32.65 ± 2.4 mV. The vaccine particles were nontoxic to normal cells at high concentrations (500 μg/2.5 × 10
5
cells) of vaccine particles. There was a significant induction of innate immune response by vaccine microparticles which was observed
in vitro
when compared to blank microparticles (
P
< 0.05). The vaccine microparticles also significantly increased the antigen presentation and co-stimulatory molecules expression on antigen presenting cells, which is a prerequisite for Th1 and Th2 immune responses. When the ODF vaccine formulation was dosed in juvenile pigs, significantly higher antibody titers were observed after week 2, with a significant increase at week 4 and plateauing through week 6 comparative to naïve predose titers. The results suggest that the ODF measles vaccine formulation is a viable dosage form alternative to noninvasive immunization that may increase patient compliance and commercial distribution.</description><identifier>ISSN: 1530-9932</identifier><identifier>EISSN: 1530-9932</identifier><identifier>DOI: 10.1208/s12249-016-0566-3</identifier><identifier>PMID: 27357420</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Administration, Buccal ; Administration, Oral ; Animals ; Biochemistry ; Biocompatible Materials - chemistry ; Biomedical and Life Sciences ; Biomedicine ; Biotechnology ; Cell Line ; Chemistry, Pharmaceutical - methods ; Drug Carriers - chemistry ; Drug Compounding - methods ; Drug Delivery Systems - methods ; Immunization - methods ; Measles Vaccine - administration & dosage ; Measles Vaccine - chemistry ; Mice ; Microspheres ; Mouth Mucosa - metabolism ; Particle Size ; Pharmacology/Toxicology ; Pharmacy ; Research Article ; Serum Albumin, Bovine - chemistry ; Swine ; Theme: Pediatric Drug Development and Dosage Form Design</subject><ispartof>AAPS PharmSciTech, 2017-02, Vol.18 (2), p.283-292</ispartof><rights>American Association of Pharmaceutical Scientists 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-fcd84d07eb36a240668b42aa3376e525655d84538a424828165749dbafe79cd63</citedby><cites>FETCH-LOGICAL-c387t-fcd84d07eb36a240668b42aa3376e525655d84538a424828165749dbafe79cd63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1208/s12249-016-0566-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1208/s12249-016-0566-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27357420$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gala, Rikhav P.</creatorcontrib><creatorcontrib>Popescu, Carmen</creatorcontrib><creatorcontrib>Knipp, Gregory T.</creatorcontrib><creatorcontrib>McCain, Robyn R.</creatorcontrib><creatorcontrib>Ubale, Ruhi V.</creatorcontrib><creatorcontrib>Addo, Richard</creatorcontrib><creatorcontrib>Bhowmik, Tuhin</creatorcontrib><creatorcontrib>Kulczar, Christopher D.</creatorcontrib><creatorcontrib>D’Souza, Martin J.</creatorcontrib><title>Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine</title><title>AAPS PharmSciTech</title><addtitle>AAPS PharmSciTech</addtitle><addtitle>AAPS PharmSciTech</addtitle><description>The aim of this study is to develop an orally disintegrating film (ODF) containing a microparticulate measles vaccine formulation for buccal delivery. The measles vaccine microparticles were made with biocompatible and biodegradable bovine serum albumin (BSA) and processed by spray drying. These vaccine microparticles were incorporated in the ODF, consisting of Lycoat RS720®, Neosorb P60W® and Tween 80. The yield of the microparticles was approximately 85–95%,
w
/
w
. The mean size of the vaccine microparticles was 3.65 ± 1.89 μm and had a slightly negative surface charge of 32.65 ± 2.4 mV. The vaccine particles were nontoxic to normal cells at high concentrations (500 μg/2.5 × 10
5
cells) of vaccine particles. There was a significant induction of innate immune response by vaccine microparticles which was observed
in vitro
when compared to blank microparticles (
P
< 0.05). The vaccine microparticles also significantly increased the antigen presentation and co-stimulatory molecules expression on antigen presenting cells, which is a prerequisite for Th1 and Th2 immune responses. When the ODF vaccine formulation was dosed in juvenile pigs, significantly higher antibody titers were observed after week 2, with a significant increase at week 4 and plateauing through week 6 comparative to naïve predose titers. The results suggest that the ODF measles vaccine formulation is a viable dosage form alternative to noninvasive immunization that may increase patient compliance and commercial distribution.</description><subject>Administration, Buccal</subject><subject>Administration, Oral</subject><subject>Animals</subject><subject>Biochemistry</subject><subject>Biocompatible Materials - chemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biotechnology</subject><subject>Cell Line</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Drug Carriers - chemistry</subject><subject>Drug Compounding - methods</subject><subject>Drug Delivery Systems - methods</subject><subject>Immunization - methods</subject><subject>Measles Vaccine - administration & dosage</subject><subject>Measles Vaccine - chemistry</subject><subject>Mice</subject><subject>Microspheres</subject><subject>Mouth Mucosa - metabolism</subject><subject>Particle Size</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Research Article</subject><subject>Serum Albumin, Bovine - chemistry</subject><subject>Swine</subject><subject>Theme: Pediatric Drug Development and Dosage Form Design</subject><issn>1530-9932</issn><issn>1530-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD1PwzAQhi0EoqXwA1hQRpaAP2LHGaEqH1KBDsBqOc6FpnLjYjeV-u9xSUFMTD7rnnt19yB0TvAVoVheB0JpVqSYiBRzIVJ2gIaEM5wWBaOHf-oBOglhgTFlpGDHaEBzxvOM4iGazubb0Bhn5rBsjLaJbqtk5sHYpv3-TzbadnrduDZxdaKTZ7cBm9x2Ztd8Ah0shORdG9O0cIqOam0DnO3fEXq7m7yOH9Lpy_3j-GaaGibzdVqbSmYVzqFkQtMMCyHLjGrNWC6AUy44jwBnUmc0k1QSEZctqlLXkBemEmyELvvclXefHYS1WjbBgLW6BdcFRSQVOS4ElhElPWq8C8FDrVa-WWq_VQSrnUTVS1RRotpJVCzOXOzju3IJ1e_Ej7UI0B4IsdV-gFcL1_k2nvxP6hc-Bns0</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Gala, Rikhav P.</creator><creator>Popescu, Carmen</creator><creator>Knipp, Gregory T.</creator><creator>McCain, Robyn R.</creator><creator>Ubale, Ruhi V.</creator><creator>Addo, Richard</creator><creator>Bhowmik, Tuhin</creator><creator>Kulczar, Christopher D.</creator><creator>D’Souza, Martin J.</creator><general>Springer US</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20170201</creationdate><title>Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine</title><author>Gala, Rikhav P. ; Popescu, Carmen ; Knipp, Gregory T. ; McCain, Robyn R. ; Ubale, Ruhi V. ; Addo, Richard ; Bhowmik, Tuhin ; Kulczar, Christopher D. ; D’Souza, Martin J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c387t-fcd84d07eb36a240668b42aa3376e525655d84538a424828165749dbafe79cd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Administration, Buccal</topic><topic>Administration, Oral</topic><topic>Animals</topic><topic>Biochemistry</topic><topic>Biocompatible Materials - chemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biotechnology</topic><topic>Cell Line</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Drug Carriers - chemistry</topic><topic>Drug Compounding - methods</topic><topic>Drug Delivery Systems - methods</topic><topic>Immunization - methods</topic><topic>Measles Vaccine - administration & dosage</topic><topic>Measles Vaccine - chemistry</topic><topic>Mice</topic><topic>Microspheres</topic><topic>Mouth Mucosa - metabolism</topic><topic>Particle Size</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Research Article</topic><topic>Serum Albumin, Bovine - chemistry</topic><topic>Swine</topic><topic>Theme: Pediatric Drug Development and Dosage Form Design</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gala, Rikhav P.</creatorcontrib><creatorcontrib>Popescu, Carmen</creatorcontrib><creatorcontrib>Knipp, Gregory T.</creatorcontrib><creatorcontrib>McCain, Robyn R.</creatorcontrib><creatorcontrib>Ubale, Ruhi V.</creatorcontrib><creatorcontrib>Addo, Richard</creatorcontrib><creatorcontrib>Bhowmik, Tuhin</creatorcontrib><creatorcontrib>Kulczar, Christopher D.</creatorcontrib><creatorcontrib>D’Souza, Martin J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>AAPS PharmSciTech</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gala, Rikhav P.</au><au>Popescu, Carmen</au><au>Knipp, Gregory T.</au><au>McCain, Robyn R.</au><au>Ubale, Ruhi V.</au><au>Addo, Richard</au><au>Bhowmik, Tuhin</au><au>Kulczar, Christopher D.</au><au>D’Souza, Martin J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine</atitle><jtitle>AAPS PharmSciTech</jtitle><stitle>AAPS PharmSciTech</stitle><addtitle>AAPS PharmSciTech</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>18</volume><issue>2</issue><spage>283</spage><epage>292</epage><pages>283-292</pages><issn>1530-9932</issn><eissn>1530-9932</eissn><abstract>The aim of this study is to develop an orally disintegrating film (ODF) containing a microparticulate measles vaccine formulation for buccal delivery. The measles vaccine microparticles were made with biocompatible and biodegradable bovine serum albumin (BSA) and processed by spray drying. These vaccine microparticles were incorporated in the ODF, consisting of Lycoat RS720®, Neosorb P60W® and Tween 80. The yield of the microparticles was approximately 85–95%,
w
/
w
. The mean size of the vaccine microparticles was 3.65 ± 1.89 μm and had a slightly negative surface charge of 32.65 ± 2.4 mV. The vaccine particles were nontoxic to normal cells at high concentrations (500 μg/2.5 × 10
5
cells) of vaccine particles. There was a significant induction of innate immune response by vaccine microparticles which was observed
in vitro
when compared to blank microparticles (
P
< 0.05). The vaccine microparticles also significantly increased the antigen presentation and co-stimulatory molecules expression on antigen presenting cells, which is a prerequisite for Th1 and Th2 immune responses. When the ODF vaccine formulation was dosed in juvenile pigs, significantly higher antibody titers were observed after week 2, with a significant increase at week 4 and plateauing through week 6 comparative to naïve predose titers. The results suggest that the ODF measles vaccine formulation is a viable dosage form alternative to noninvasive immunization that may increase patient compliance and commercial distribution.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>27357420</pmid><doi>10.1208/s12249-016-0566-3</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1530-9932 |
| ispartof | AAPS PharmSciTech, 2017-02, Vol.18 (2), p.283-292 |
| issn | 1530-9932 1530-9932 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1826709608 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Administration, Buccal Administration, Oral Animals Biochemistry Biocompatible Materials - chemistry Biomedical and Life Sciences Biomedicine Biotechnology Cell Line Chemistry, Pharmaceutical - methods Drug Carriers - chemistry Drug Compounding - methods Drug Delivery Systems - methods Immunization - methods Measles Vaccine - administration & dosage Measles Vaccine - chemistry Mice Microspheres Mouth Mucosa - metabolism Particle Size Pharmacology/Toxicology Pharmacy Research Article Serum Albumin, Bovine - chemistry Swine Theme: Pediatric Drug Development and Dosage Form Design |
| title | Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine |
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